ISO 11137-2 PDF

Buy EN ISO STERILIZATION OF HEALTH CARE PRODUCTS – RADIATION – PART 2: ESTABLISHING THE STERILIZATION DOSE (ISO. ISO Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose. ANSI/AAMI/. ISO Sterilization of health care products — Radiation —. Part 2: Establishing the sterilization dose. American. National. Standard.

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The number of samples required for this testing should be confirmed with the laboratory performing the testing usually Furthermore, the validation is less expensive because fewer tests are necessary. This Method should be used when the lowest possible isp dose is desired due to cost considerations, use of gamma sensitive materials, or when the bioburden count is above CFU.

EN ISO 11137-2:2015

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This is considered an overdose. Send iao samples for irradiation prior to sterility testing. When gamma irradiation is selected for product sterilization, the dose at which the product is irradiated must be established and validated in accordance with appropriate AAMI standards.


Its use today has been discontinued. Population of viable microorganisms on a product.

Setting the maximum dose as high as possible allows the greatest flexibility in processing schedules when product is ready for routine sterilization. Test performed with selected microorganisms to demonstrate the presence of substances that inhibit the multiplication of these microorganisms. Establishing the sterilization dose Status: Are there other options for dose setting besides VDmax25 and Method 1?

EN ISO – Sterilization of health care products – Radiation – Part 2: –

Irradiating your product at a dose approximately 2. We use cookies to make our website easier to use and to better understand your needs. The faster, easier way to work with standards. Probability of a viable microorganism being present on a product unit after sterilization.

Gamma Sterilization Validations VDmax 25 and Method 1

Bacillus pumilus, a spore-forming microorganism, served for many years as a biological indicator to test for sterility. It also defines product families for establishing sterilization doses and gives details on a sterilization dose audit. Please download Chrome or Firefox or view our browser tips.

What are the basic steps? A correction of the language used to describe the requirements for interpretations of results during a verification dose experiment Amendments to methods of dose establishment and means of substantiation Changes to the incremental increases in the bioburden values have been included in Table 6.


These TIRs reflect common industry practices that evolve from an accumulated process knowledge base. The radiation resistance of B. Sterilization of health care products-Radiation-Part 2: Pre- and postirradiation properties related to functionality and appearance must be evaluated to determine maximum dose. Sterilization of health care products-Radiation-Part 1: Isk may experience issues viewing this site in Internet Explorer 9, 10 or If one of these validations establishes my minimum dose, how do I establish a maximum dose?

Gamma Sterilization Validations: VDmax 25 and Method 1 FAQ | STERIS AST

Your basket is empty. Search all products by. Accelerated aging and package testing are additional tests to be considered for product irradiated at the maximum dose.

This must be retested if any changes are made to the product. Overview Product Details What is this standard about? The standard has been systematically reviewed by experts to ensure its continued market relevance and adherence to clinical best practice and now includes significant technical changes such as: